Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"

Pediatric Crohn's Disease Clinical Trial

Official title:

Post-Marketing Surveillance of Humira in Korean Pediatric CD Patients Under the "New-Drug Re-examination"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578238
• Other study ID #: P15-619
• Status: Completed
• Start date: September 24, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: May 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling)

• Patients who have given written authorization to use their personal health data for the purposes of this study.

Exclusion Criteria:

• Any contraindications to Humira as listed on the approved product market authorization (labeling)

• Patients who is participating on other clinical trials.

Related Conditions & MeSH terms

• Crohn Disease
• Pediatric Crohn's Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs	An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded.	From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).

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